Status:
WITHDRAWN
Study Evaluating Retinal Health Monitoring System Thickness Module
Lead Sponsor:
Kubota Vision Inc.
Conditions:
Macular Edema
Macular Degeneration
Eligibility:
All Genders
18+ years
Brief Summary
Evaluate the ability and accuracy of the Retinal Health Monitoring System - Retinal Thickness Module (RHMS - RTM).
Detailed Description
Evaluation of the Retinal Health Monitoring System - Retinal Thickness Module in subjects with normal macular thickness and subjects with center-involving macular edema.
Eligibility Criteria
Inclusion
- Corrected visual acuity (VA) of 20/100 or better, in the study eye(s)
- Media clarity, undilated pupil size, OCT-B scans, axial length measurements in the study eye(s)
- Able to perform self-testing of retinal thickness with the RHMS-RTM after training
- Able and willing to give informed consent
- Group 1:
- Macula with normal thickness \[central subfield thickness (CST) below 305 microns as measured by SD-OCT\] in at least one eye
- Patients with dry AMD are eligible for enrollment into Group 1
- No history of wet AMD, DR, or RVO in either eye
- Group 2 and Group 3 (in at least one or the same eye):
- History of center-involving macular edema due to wet AMD (Group 2); or DR or RVO (Group 3)
- Macular edema on SD-OCT with CST ≥ 305 microns
Exclusion
- History of corneal refractive surgery, photorefractive keratectomy, radial keratotomy, in the study eye
- History of epiretinal membrane, vitreomacular traction, or macular hole in the study eye(s)
- Participation in any study using an investigational drug within 30 days or screening or investigational device within 60 days of screening
- Refractive error: spherical equivalent of \> 3 diopters of hyperopia or \> 6 diopters of myopia, or \> 2 diopters cylinder in the study eye(s)
- History of photocoagulation laser scar or other retinal scar in the central 3 mm of the macula, in the study eye(s)
Key Trial Info
Start Date :
April 1 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 1 2020
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04428242
Start Date
April 1 2020
End Date
July 1 2020
Last Update
February 21 2021
Active Locations (1)
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1
Retinal Consultants Medical Group, Inc
Sacramento, California, United States, 95819